HEARTPORT THORACIC SURGICAL TROCARS: (TOST-4-3, TOSTL-6-3, TON-4-2 AND TONL-6-2— 510(k) K961463
Substantially EquivalentHeartport, Inc.
FDA 510(k) clearance K961463 for HEARTPORT THORACIC SURGICAL TROCARS: (TOST-4-3, TOSTL-6-3, TON-4-2 AND TONL-6-2, Substantially Equivalent on 1996-10-08. Applicant: Heartport, Inc.. Device class: 2.
Clearance details
- Applicant
- Heartport, Inc.
- Product code
- Code GCJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Redwood City, CA, US
Recent devices under product code GCJ
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- K261139 — VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)
- K253541 — EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)
More clearances from Heartport, Inc.
view all- K994243 — DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT TIP, STRAIGHTSHOT KIT, 23 FR, ANGLED TIP
- K981995 — QUICKDRAW VENOUS CANNULA
- K990772 — DIRECTFLOW ARTERIAL CANNULA
- K981009 — HEARTPORT ENDOPULMONARY VENT CATHETER
- K974736 — HEARTPORT DIRECT AORTIC RETURN CANNULA WITH INTRODUCER
Adverse events under product code GCJ
product code GCJ- Death
- 39
- Injury
- 1,638
- Malfunction
- 28,216
- Other
- 11
- Total
- 29,904
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.